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Background The importance of albuminuria as opposed to proteinuria in predicting kidney outcomes in primary immunoglobulin A nephropathy (IgAN) is not well established. Methods From 2010 to 2012, 421 patients with biopsy-proven IgAN have been enrolled into the German Chronic Kidney Disease (GCKD) cohort, a prospective observational cohort study (N  = 5217). Adjudicated endpoints include a composite kidney endpoint (CKE) consisting of eGFR decline >40%, eGFR <15 ml/min/1.73 m2 and initiation of kidney replacement therapy; the individual components of the CKE; and combined major adverse cardiac events (MACE), including non-fatal myocardial infarction, non-fatal stroke and all-cause mortality. The associations between the incidence of CKE and baseline factors, including demographics, laboratory values and comorbidities were analysed using the Cox proportional hazards regression model. Results The mean age of IgAN patients at baseline was 51.6 years (± 13.6) and 67% were male. The patient-reported duration of disease at baseline was 5.9 ± 8.1 years. Baseline median urine albumin:creatinine ratio (UACR) was 0.4 g/g [interquartile range (IQR) 0.1–0.8] and mean eGFR was 52.5 ± 22.4 ml/min/1.73 m2. Over a follow-up of 6.5 years, 64 (15.2%) patients experienced a >40% eGFR decline, 3 (0.7%) reached eGFR <15 ml/min/1.73 m2, 53 (12.6%) initiated kidney replacement therapy and 28% of the patients experienced the CKE. Albuminuria, with reference to <0.1 g/g, was most associated with CKE. Hazard ratios (HRs) at UACRs of 0.1–0.6 g/g, 0.6–1.4 g/g, 1.4–2.2 g/g and >2.2 g/g were 2.03 [95% confidence interval (CI) 1.02–4.05], 3.8 (95% CI 1.92–7.5), 5.64 (95% CI 2.58–12.33) and 5.02 (95% CI 2.29–11-03), respectively. Regarding MACE, the presence of diabetes [HR 2.53 (95% CI 1.11–5.78)] was the most strongly associated factor, whereas UACR and eGFR did not show significant associations. Conclusion In the GCKD IgAN subcohort, more than every fourth patient experienced a CKE event within 6.5 years. Our findings support the use of albuminuria as a surrogate to assess the risk of poor kidney outcomes. [ABSTRACT FROM AUTHOR]

Background Focal segmental glomerulosclerosis (FSGS) can lead to kidney failure in adults. This study examines the progression of FSGS in the German Chronic Kidney Disease (GCKD) cohort. Methods The GCKD study (N  = 5217), a prospective cohort, included 159 patients with biopsy-confirmed FSGS recruited from 2010 to 2012. Baseline was defined as the first study visit. Adjudicated endpoints included a composite kidney endpoint (CKE), including an estimated glomerular filtration rate (eGFR) decrease >40%, eGFR <15 ml/min/1.73 m2 or initiation of kidney replacement therapy and combined major adverse cardiovascular events (MACE), including non-fatal myocardial infarction or stroke and all-cause mortality. Associations between baseline demographics, laboratory data, comorbidity and CKE and MACE were analysed using the Cox proportional hazards regression model. Results The mean age at baseline was 52.1 ± 13.6 years, with a disease duration of 4.72 years (quartile 1: 1; quartile 3: 6) before joining the study. The median urinary albumin:creatinine ratio (UACR) at baseline was 0.7 g/g (IQR 0.1;1.8), while mean eGFR was 55.8 ± 23 ml/min/1.73 m2. Based on clinical and pathological features, 69 (43.4%) patients were categorized as primary FSGS, 55 (34.6%) as secondary FSGS and 35 (22%) as indeterminate. Over a follow-up of 6.5 years, 44 patients reached the composite kidney endpoint and 16 individuals had at least one MACE. UACR ≥0.7 g/g was strongly associated with both the composite kidney endpoint {hazard ratio [HR] 5.27 [95% confidence interval (CI) 2.4–11.5]} and MACE [HR 3.37 (95% CI 1.05–10.82)] compared with <0.7 g/g, whereas a higher eGFR at baseline (per 10 ml/min) was protective for both endpoints [HR 0.8 (95% CI 0.68–0.95) and HR 0.63 (95% CI 0.46–0.88), respectively]. Patients with secondary FSGS experienced a greater rate of eGFR decline than patients with primary FSGS. Conclusions Lower eGFR and higher albuminuria are key risk factors for kidney disease progression and cardiovascular events in patients with FSGS. [ABSTRACT FROM AUTHOR]

(1) Background: This retrospective study focused on severe acute respiratory distress syndrome (ARDS) patients treated with veno-venous (VV) extracorporeal membrane oxygenation (ECMO) and who inhaled nitric oxide (NO) for pulmonary arterial hypertension (PAH) and/or right ventricular failure (RV failure). (2) Methods: Out of 662 ECMO-supported patients, 366 received VV ECMO, including 48 who inhaled NO. We examined the NO's indications, dosing, duration, and the ability to lower PAH. We compared patients with and without inhaled NO in terms of mechanical ventilation duration, ECMO weaning, organ dysfunction, in-hospital mortality, and survival. (3) Results: Patients received 14.5 ± 5.5 ppm NO for 3 days with only one-third experiencing decreased pulmonary arterial pressure. They spent more time on VV ECMO, had a higher ECMO weaning failure frequency, and elevated severity scores (SAPS II and TIPS). A Kaplan–Meier analysis revealed reduced survival in the NO group. Multiple variable logistic regression indicated a twofold increased risk of death for ARDS patients on VV ECMO with NO. We observed no increase in continuous renal replacement therapy. (4) Conclusions: This study suggests that persistent PAH and/or RV failure is associated with poorer outcomes in severe ARDS patients on VV-ECMO, with an inhaled NO responder rate of only 30%, and it does not impact acute kidney failure rates. [ABSTRACT FROM AUTHOR]

Background Diabetes mellitus (DM) and chronic kidney disease (CKD) are well-known cardiovascular and mortality risk factors. To what extent they act in an additive manner and whether the etiology of CKD modifies the risk is uncertain. Methods The multicenter, prospective, observational German Chronic Kidney Disease study comprises 5217 participants (1868 with DM) with a baseline mean estimated glomerular filtration rate of 30–60 mL/min/1.73 m2 and/or proteinuria >0.5 g/day. We categorized patients whose CKD was caused by cardiovascular or metabolic diseases (CKDcvm) with and without DM, as opposed to genuine CKD (CKDgen) with and without DM. Recorded outcomes were first events of non-cardiovascular and cardiovascular death, 4-point major adverse cardiovascular events (4-point MACE) and hospitalization for heart failure (HHF). Results During the 6.5-year follow-up 603 (12%) non-cardiovascular and 209 (4%) cardiovascular deaths, 645 (12%) 4-point MACE, and 398 (8%) HHF were observed, most frequently in patients with DM having CKDcvm. DM increased the risk of non-cardiovascular [hazard ratio (HR) 1.92; 95% confidence interval (CI) 1.59–2.32] and cardiovascular (HR 2.25; 95% CI 1.62–3.12) deaths, 4-point MACE (HR 1.93; 95% CI 1.62–2.31) and HHF (HR 1.87; 95% CI 1.48–2.36). Mortality risks were elevated by DM to a similar extent in CKDcvm and CKDgen, but for HHF in CKDcvm only (HR 2.07; 95% CI 1.55–2.77). In patients with DM, CKDcvm (versus CKDgen) only increased the risk for HHF (HR 1.93; 95% CI 1.15–3.22). Conclusions DM contributes to cardiovascular and mortality excess risk in patients with moderate to severe CKD in both, CKDcvm and CKDgen. Patients with DM and CKDcvm are particularly susceptible to HHF. [ABSTRACT FROM AUTHOR]

Mineral and bone disorder (MBD) in chronic kidney disease (CKD) is tightly linked to cardiovascular disease (CVD). In this study, we aimed to compare the prognostic value of nine MBD biomarkers to determine those associated best with adverse cardiovascular (CV) outcomes and mortality. In 5 217 participants of the German CKD (GCKD) study enrolled with an estimated glomerular filtration rate (eGFR) between 30–60 mL·min−1 per 1.73 m2 or overt proteinuria, serum osteoprotegerin (OPG), C-terminal fibroblast growth factor-23 (FGF23), intact parathyroid hormone (iPTH), bone alkaline phosphatase (BAP), cross-linked C-telopeptide of type 1 collagen (CTX1), procollagen 1 intact N-terminal propeptide (P1NP), phosphate, calcium, and 25-OH vitamin D were measured at baseline. Participants with missing values among these parameters (n = 971) were excluded, leaving a total of 4 246 participants for analysis. During a median follow-up of 6.5 years, 387 non-CV deaths, 173 CV deaths, 645 nonfatal major adverse CV events (MACEs) and 368 hospitalizations for congestive heart failure (CHF) were observed. OPG and FGF23 were associated with all outcomes, with the highest hazard ratios (HRs) for OPG. In the final Cox regression model, adjusted for CV risk factors, including kidney function and all other investigated biomarkers, each standard deviation increase in OPG was associated with non-CV death (HR 1.76, 95% CI: 1.35–2.30), CV death (HR 2.18, 95% CI: 1.50–3.16), MACE (HR 1.38, 95% CI: 1.12–1.71) and hospitalization for CHF (HR 2.05, 95% CI: 1.56–2.69). Out of the nine biomarkers examined, stratification based on serum OPG best identified the CKD patients who were at the highest risk for any adverse CV outcome and mortality. [ABSTRACT FROM AUTHOR]

Purpose: Report on the diagnosis of prenatally detected fetal kidneys with bilateral polycystic appearance in a single center between 1999 and 2020 with special focus on renal morphology and biometry, amniotic fluid and extrarenal findings and proposal for an diagnostic algorithm. Methods: Retrospective observational study including pregnancies with prenatally detected kidneys with bilateral polycystic appearance (n = 98). Cases and outcomes were compared according to prenatal findings with special focus on renal morphology, amount of amniotic fluid, and presence of extrarenal abnormalities. Results: Most frequent diagnoses were autosomal recessive polycystic kidney disease (ARPKD, 53.1%), Meckel–Gruber syndrome (MKS, 17.3%) and autosomal dominant polycystic kidney disease (ADPKD, 8.2%). Other diagnoses included: Joubert-, Jeune-, McKusick–Kaufman- and Bardet–Biedl syndrome, overgrowth syndromes, Mainzer–Saldino syndrome and renal tubular dysgenesis. Renal abnormalities most frequently observed were hyperechogenic parenchyma, kidney enlargement, changes of corticomedullary differentiation and cystic changes of various degree. Oligo- and anhydramnios were mainly seen in ARPKD, RTD and second-trimester MKS. Extrarenal findings included skeletal (35.7%) and cardiac (34.7%) abnormalities as well as abnormalities of the central nervous system (27.6%). Conclusion: Gestational age at manifestation, kidney size, visibility of cysts, echogenicity, amniotic fluid volume, and the presence of associated extrarenal malformations allow to differentiate between the most frequent underlying diseases presenting with bilateral polycystic kidneys on prenatal ultrasound by following a diagnostic algorithm. [ABSTRACT FROM AUTHOR]

Background Osteopontin (OPN), synthesized in the thick ascending limb of Henle's loop and in the distal tubule, is involved in the pathogenesis of kidney fibrosis, a hallmark of kidney failure (KF). In a cohort of chronic kidney disease (CKD) patients, we evaluated OPN's association with kidney markers and KF. Methods OPN was measured from baseline serum samples of German Chronic Kidney Disease study participants. Cross-sectional regression models for estimated glomerular filtration rate (eGFR) and urinary albumin-to-creatinine ratio (UACR) as well as Cox regression models for all-cause mortality and KF were evaluated to estimate the OPN effect. Additionally, the predictive ability of OPN and time-dependent population-attributable fraction were evaluated. Results Over a median follow-up of 6.5 years, 471 KF events and 629 deaths occurred among 4950 CKD patients. One-unit higher log(OPN) was associated with 5.5 mL/min/1.73 m2 lower eGFR [95% confidence interval (95% CI) –6.4 to –4.6] and 1% change in OPN with 0.7% higher UACR (estimated effect 0.7, 95% CI 0.6–0.8). Moreover, higher OPN levels were associated with a higher risk of KF [hazard ratio (HR) 1.4, 95% CI 1.2–1.7] and all-cause mortality (HR 1.5, 95% CI 1.3–1.8). After 6 years, 31% of the KF events could be attributed to higher OPN levels (95% CI 3%–56%). Conclusions In this study, higher OPN levels were associated with kidney function markers worsening and a higher risk for adverse outcomes. A larger proportion of KF could be attributed to higher OPN levels, warranting further research on OPN with regards to its role in CKD progression and possible treatment options. [ABSTRACT FROM AUTHOR]

Intraoperative auditory brainstem response (ioABR) testing following tympanostomy tube (TT) placement may be biased due to temporary threshold shifts (TTS). The purpose of the study was to assess the evidence for TTS in children who have undergone ioABR using prolonged latencies of wave I (males > 1.95 ms, females > 1.88 ms) as a marker of a persisting air–bone gap. Eighty-three children underwent ioABR following surgical procedures at University Hospital Bonn, Germany. The primary outcome measure was the latency of wave I at 80-dB SPL. The total sample consisted of 66 males (79.5%) and 17 females (20.5%) with a mean (SD) age of 46.4 (26.6) months. Of 163 operated ears (83 children), 72 (44.2%) had no middle ear fluid, 19 (11.6%) serous fluid, and 72 (44.2%) mucoid fluid. The risk of having a prolonged latency of wave I at 80-dB SPL was OR 4.61 (95% CI 2.01–10.59; p < 0.001) in those with mucoid fluid as compared to those without mucoid fluid. Intraoperative ABR results should account for sex differences and be interpreted with caution and be verified. Ultimately, parents should be engaged in a preoperative discussion to decide if an ioABR should be postponed if mucoid fluid was found. [ABSTRACT FROM AUTHOR]

Background: One anastomosis gastric bypass (OAGB) has become increasingly accepted in bariatric surgery and meanwhile represents the third most common procedure worldwide. While it shows promising weight loss results and comorbidity resolution, questions about issues such as reflux or nutritional deficiencies (ND) persist in the long term. On the other hand, the most frequently performed sleeve gastrectomy (SG) has to accept growing criticism regarding long-term results and reflux issues. There is a particular lack of long-term comparative data for both procedures. This study presents our long-term experience.Methods: We evaluated OAGB and SG patients retrospectively comparing for weight loss and resolution of comorbidities as well as perioperative and long-term complications in a follow-up period of 5 years.Results: Nine hundred eleven OAGB and 241 SG were included in the study. OAGB had a shorter operation time and hospital stay. Overall complication rate did not differ in both groups. Ulcers were more frequent in OAGB (7.7% vs. 1.7%, p = 0.001), whereas insufficient weight loss (IWL)/weight regain (WR) proved to be more prevalent in SG (25.7% vs. 6.4%, p < 0.001). The same held true for reflux (17.8% vs. 8.3%, p < .001). On the other hand, ND were more common in OAGB (20.0% vs. 12.0%, p = 0.005). Revisional surgery was more often indicated after SG. Analysis by linear mixed model showed that OAGB achieved a lower BMI/higher loss of BMI. Improvement of T2DM (94.6% vs. 85.2%, p = 0.008) and sleep apnea (88.8% vs. 78.8%, p = 0.01) was superior in OAGB.Conclusions: OAGB had a superior effect on weight loss as well as improvement of T2DM and sleep apnea. Furthermore, long-term problems such as IWL/WR and reflux were more related to SG. On the other hand, a malabsorptive procedure such as OAGB showed a higher risk for ND. Our findings support the available data in the literature. [ABSTRACT FROM AUTHOR]

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Background Brolucizumab has recently been approved in Europe as a novel treatment for patients with neovascular age-related macular degeneration (nAMD). We report on early experiences with real-world outcomes of switch to brolucizumab therapy in previously anti-vascular endothelial growth factor (anti-VEGF)- treated patients. Methods Patients with recalcitrant nAMD were switched to brolucizumab therapy. Functional and structural parameters 4 weeks after first brolucizumab injection were evaluated including best-corrected visual acuity (BCVA (logMAR)), foveal centre point (FCP (µm)), central subfield retinal thickness (CSRT (µm)) and macular volume (mm2). Results Sixty-three eyes of 57 patients with nAMD (52.6% females) with a mean (±SD) age of 79.5±6.7 years were included. Mean change of BCVA was 0.03±0.14 logMAR (p=0.115). Significant reductions were recorded for FCP with a mean (±SD) change of -66.81±72.63 µm, -66.76±60.71 µm for CSRT and -0.27±0.24 mm2 for macular volume (all p<0.001). Intraocular inflammation was observed in seven eyes of seven patients, including one case of retinal vasculitis. Conclusions The results of the SHIFT study indicate that switch to brolucizumab may represent a treatment option in patients with nAMD poorly responsive to other anti-VEGF agents. Further long-term analyses appear prudent to assess efficacy and safety of brolucizumab in a routine clinical setting. [ABSTRACT FROM AUTHOR]

Background/objectives: A diet following chronic kidney disease (CKD)-specific recommendations is considered essential for optimal management of patients with CKD. However, data on the adherence to these recommendations and its implications for health-relevant biomarkers are lacking. The objectives were to estimate adherence to CKD-specific dietary recommendations, to identify characteristics and lifestyle variables associated with poor adherence, and to investigate the relationship of adherence with biomarkers.Methods: In this cross-sectional analysis, average dietary intake was estimated in 3193 participants with moderately severe CKD enrolled into the observational multicenter German CKD study using a food frequency questionnaire. A CKD diet score was developed to assess adherence to CKD-specific dietary recommendations based on intake of sodium, potassium, fiber, protein, sugar, and cholesterol. The associations of dietary adherence with characteristics, lifestyle variables, and biomarker levels were determined.Results: Logistic regression analysis revealed younger age, higher body mass index, male gender, lower educational attainment, various lifestyle variables (cigarette smoking, infrequent alcohol consumption, low physical activity), and lower estimated glomerular filtrate rate associated with lower adherence to dietary recommendations. Low adherence to dietary recommendations was further associated with dyslipidemia, higher uric acid, and C-reactive protein levels. Associations between low dietary adherence and biomarkers were mostly driven by low intake of fiber and potassium, and high intake of sugar and cholesterol.Conclusions: This study revealed differential characteristics and biomarkers associated with lower adherence to CKD-specific dietary recommendations. Promotion of CKD-specific dietary recommendations may help to mitigate the adverse prognosis in CKD patients. [ABSTRACT FROM AUTHOR]

Purpose: To compare the safety and effectiveness of coil versus glue embolization of gastroesophageal varices during transjugular intrahepatic portosystemic shunt (TIPS) creation. Materials and Methods: In this monocentric retrospective study 104 (males: 67 (64%)) patients receiving TIPS with concomitant embolization of GEV and a minimum follow-up of one year (2008—2017) were included. Primary outcome parameter was overall survival (6 week; 1 year). Six-week overall survival was assessed as a surrogate for treatment failure as proposed by the international Baveno working group. Secondary outcome parameters were development of acute-on-chronic liver failure (ACLF), variceal rebleeding and hepatic encephalopathy (HE). Survival analysis was performed using Kaplan–Meier with log-rank test and adjusted Cox regression analysis. Results: Indications for TIPS were refractory ascites (n = 33) or variceal bleeding (n = 71). Embolization was performed using glue with or without coils (n = 40) (Group G) or coil-only (n = 64) (Group NG). Overall survival was significantly better in group G (p = 0.022; HR = -3.333). Six-week survival was significantly lower in group NG (p = 0.014; HR = 6.945). Rates of development of ACLF were significantly higher in group NG after 6 months (NG = 14; G = 6; p = 0.039; HR = 3.243). Rebleeding rates (NG = 6; G = 3; p = 0.74) and development of HE (NG = 22; G = 15; p = 0.75) did not differ significantly between groups. Conclusion: Usage of glue in embolization of GEV may improve overall survival, reduce treatment failure and may be preferable over coil embolization alone. [ABSTRACT FROM AUTHOR]

Background: To characterise early stages of geographic atrophy (GA) development in age-related macular degeneration (AMD) and to determine the prognostic value of structural precursor lesions in eyes with intermediate (i) AMD on the subsequent GA progression. Methods: Structural precursor lesions for atrophic areas (lesion size at least 0.5 mm² in fundus autofluorescence images) were retrospectively identified based on multimodal imaging and evaluated for association with the subsequent GA enlargement rates (square-root transformed, sqrt). A linear mixed-effects model was used to account for the hierarchical nature of the data with a Tukey post hoc test to assess the impact of the local precursor on the subsequent GA progression rate. Results: A total of 39 eyes with GA of 34 patients with a mean age of 74.4±6.7 (±SD) years were included in this study. Five precursor lesions (phenotypes 1-5) preceding GA development were identified: large, sub-retinal pigment epithelial drusen (n=19), reticular pseudodrusen (RPD, n=10), refractile deposits (n=4), pigment epithelial detachment (n=4) and vitelliform lesions (n=2). Precursor lesions exhibited a significant association with the subsequent (sqrt) GA progression rates (p=0.0018) with RPD (phenotype 2) being associated with the fastest GA enlargement (2.29±0.52 (±SE) mm/year. Conclusions: The results indicate the prognostic relevance of iAMD phenotyping for subsequent GA progression highlighting the role of structural AMD features across different AMD stages. [ABSTRACT FROM AUTHOR]

Purpose: Labor is a complex process involving multiple para-, auto- and endocrine cascades. The interaction of cortisol, corticotropin-releasing hormone (CRH) and progesterone is essential. The action of cortisol on the human feto-placental unit is regulated by 11beta-hydroxysteroid dehydrogenase type 2 (11β-HSD2/HSD11B2) that converts cortisol into inactive cortisone. The majority of studies on the assessment of placental 11β-HSD2 function determined indirect activity parameters. It remains elusive if indirect measurements correlate with enzymatic function and if these parameters are affected by potential confounders (e.g., mode of delivery). Thus, we compared determinants of indirect 11β-HSD2 tissue activity with its direct enzymatic turnover rate in placental samples from spontaneous births and cesarean (C)-sections. Methods: Using LC–MS/MS, we determined CRH, cortisol, cortisone, progesterone and 17-hydroxy(OH)-progesterone in human term placentas (spontaneous birth vs. C-section, n = 5 each) and measured the enzymatic glucocorticoid conversion rates in placental microsomes. Expression of HSD11B1, 2 and CRH was determined via qRT-PCR in the same samples. Results: Cortisol–cortisone ratio correlated with direct microsomal enzymatic turnover. While this observation seemed independent of sampling site, a strong influence of mode of delivery on tissue steroids was observed. The mRNA expression of HSD11B2 correlated with indirect and direct cortisol turnover rates in C-section placentas only. In contrast to C-sections, CRH, cortisol and cortisone levels were significantly increased in placental samples following spontaneous birth. Conclusion: Labor involves a series of complex hormonal processes including activation of placental CRH and glucocorticoid metabolism. This has to be taken into account when selecting human cohorts for comparative analysis of placental steroids. [ABSTRACT FROM AUTHOR]

Background Despite a plethora of studies on the effect of urate-lowering therapy (ULT) in patients with chronic kidney disease (CKD), current guidelines on the treatment of hyperuricaemia and gout vary, especially concerning the need for dose adjustment of allopurinol, whose main metabolite is accumulating with declining renal function. Data on allopurinol dosing and its relationship to renal function, co-medication and sex and the resulting urate level in large cohorts are missing. Methods We studied a subgroup of 2378 patients of the German Chronic Kidney Disease (GCKD) study to determine prescription patterns of ULT among CKD patients under nephrological care and the relationship of ULT dose to urate levels. Prescription and dosing of ULT were manually abstracted from the patient's paper charts at the baseline visit, in which all currently used medications and their dosing were recorded. Results In this cohort, 39.6% were women, the mean estimated glomerular filtration rate (eGFR) was 51.3 ± 19.3 mL/min/1.73 m2 and the mean age was 59.0 ± 12.4 years. Of the 2378 examined patients, 666 (28.0%) received ULT. The dose of ULT was available for 572 patients. The main ULT agent was allopurinol (94.4%), followed by febuxostat (2.9%) and benzbromarone (2.6%). Of the 540 patients who used allopurinol with a reported daily dose, 480 had an eGFR <60 mL/min/1.73 m2 and 320 had an eGFR <45 mL/min/1.73 m2, 31.5% of the latter (n  = 101) received a dose >150 mg/day, the recommended maximal dose for this level of eGFR. The prescribed dose was not related to eGFR: the median eGFR for patients taking 100, 150 and 300 mg/day was 40 [interquartile range (IQR) 32–49], 43 (34–52) and 42 (35–54) mL/min/1.73 m2, respectively. Patients with lower doses of allopurinol had higher serum urate levels than patients with higher (than recommended) allopurinol doses. Sex, alcohol intake, eGFR, use of diuretics and treatment with allopurinol were independent determinants of serum urate levels in multivariate regression analysis. Conclusions The most frequently used drug to lower serum urate levels in this CKD cohort was allopurinol. Even in patients regularly seen by nephrologists, the dose of allopurinol is often not adjusted to the current eGFR. Patients with higher ULT doses achieved better control of their serum urate levels. Lowering of serum urate in CKD patients requires balancing potential adverse effects of allopurinol with suboptimal control of serum urate levels. [ABSTRACT FROM AUTHOR]

Aim: The repair of restorations is an eligible method to extend the survival rates of intraoral restorations. There is a consensus that the old surface has to be removed before repair by the use of a sandblaster or rotating instruments. This study aimed to investigate whether a glycine powder can be used successfully in composite repair by measurement of shear and tensile bond strength according to dental standards. Methodology: The influence of mechanical preparation by no powder, 25 µm glycine powder or 50 µm aluminium-oxide powder and chemical conditioning by the use of bonding, phosphoric acid and bonding or bonding, phosphoric acid and a silane on the repair bond strength of an artificially aged nano-hybrid composite was tested according to the guidelines of DIN 13990 (2017), ISO 29022 (2013) and ISO/TS 11405 (2015). The fracture modes were evaluated by adhesive, cohesive or mixed failures. Results: There was no significant difference in the performance of the different mechanical and chemical treatments. The shear bond test according to DIN 13990 (2017) produces higher repair bond strengths (26.0±8.9 MPa) than the test described in ISO 29022 (17.9±6.3 MPa). The tensile bond strength according to ISO/TS 11405 (6.9±1.8 MPa) was the lowest. Most adhesive failures occurred with the shear test according to ISO 29022 (41%), followed by DIN 13990 (18%) and the tensile test (4%). Conclusion: For evaluating the bond strength of composites the test described in ISO 29022 is recommended, because it produces the highest percentage of adhesive failures. Nano-hybrid-composites are robust to different repair protocols. [ABSTRACT FROM AUTHOR]

Background Epicardial adipose tissue (EAT) exerts cardiopathogenic effects, but the independent association between EAT and cardiovascular (CV) calcification in patients with chronic kidney disease (CKD) remains controversial. We therefore assessed the association between EAT, CV risk factors and CV calcifications. Methods 257 patients with CKD Stage 3 and/or overt proteinuria underwent quantification of EAT, coronary artery calcification and aortic valve calcification by computed tomography. Framingham and American College of Cardiology and American Heart Association (ACC-AHA) 10-year CV event risk scores were calculated for each patient. Results Using multivariable regression analysis, higher EAT was significantly associated with the majority of investigated risk factors {higher age: odds ratio [OR] 1.05/year [95% confidence interval (CI) 1.02–1.08]; male sex: OR 4.03 [95% CI 2.22–7.31]; higher BMI: OR 1.28/kg/m2 [95% CI 1.20–1.37]; former smoking: OR 1.84 [95% CI 1.07–3.17]; lower high-density lipoprotein cholesterol: OR 0.98/mg/dL [95% CI 0.96–1.00] and lower estimated glomerular filtration rate: OR 0.98/mL/min/1.73 m2 [95% CI 0.97–0.99]; all P < 0.05} and was not associated with diabetes mellitus, hypertensive nephropathy, total cholesterol and albuminuria. EAT was positively associated with higher ACC-AHA and Framingham risk scores. EAT correlated with coronary artery calcification and aortic valve calcification [Spearman ρ = 0.388 (95% CI 0.287–0.532) and r rb = 0.409 (95% CI 0.310–0.556), respectively], but these correlations were dependent on CV risk factors. Conclusions The increase of EAT can be explained by individual CV risk factors and kidney function and correlates with 10-year risk for CV event scores, suggesting that EAT is a modifiable risk factor in patients with CKD. Although EAT correlates with CV calcifications, these relations depend on CV risk factors. [ABSTRACT FROM AUTHOR]

Purpose: Based on exudative activity, choroidal neovascularization (CNV) in age-related macular degeneration (AMD) can be classified as "active" aCNV, pretherapied "silent" sCNV (i.e., a treatment-free interval >12 weeks), or treatment-naïve "quiescent" qCNV. We evaluated the qualitative and quantitative optical coherence tomography angiography (OCTA) features of these CNV subgroups. Methods: The presence of small-caliber vessels, peripheral arcades, and a -perilesional OCTA signal attenuation as well as values for vessel length, density, and branching index were evaluated for each CNV network in a 6 × 6 mm OCTA scan pattern. Results: Fifty-one eyes of 51 patients with AMD (age 75.9 ± 7.5 years; 20 males [39.2%]) were included. The qCNV subgroup (n = 8) showed the highest prevalence of qualitative and quantitative values for OCTA activity criteria, reaching significance with regard to small-caliber vessels (p = 0.003), peripheral arcades (p = 0.039), vessel length (p = 0.020), and branching index (p < 0.001) when compared to the aCNV (n = 32) and sCNV (n = 11) subgroups. Qualitative criteria were inversely associated with the number of previous anti-VEGF injections (each p < 0.03), while quantitative metrics also suggested lower values. Conclusions: These findings suggest that OCTA may be supportive in the phenotypical differentiation of CNV lesions secondary to AMD, while the assessed structural changes appeared to be more indicative of previously administered anti-VEGF therapy than current exudative activity. [ABSTRACT FROM AUTHOR]

Aim: To assess the prevalence and severity of periodontitis in patients with moderate chronic kidney disease (CKD) and comparing the results with the self‐reported periodontitis awareness of the study subjects. Material and methods: The periodontal status of 270 patients with moderate CKD randomly selected from a cohort of 5,217 subjects participating in the prospective observational German Chronic Kidney Disease (GCKD) project was analysed by recording bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL). Furthermore, the awareness of the study subjects of their periodontal conditions was evaluated by a self‐reported questionnaire. Results: 24.4% of the CKD study patients showed no or only mild signs of periodontal disease, 47.6% displayed moderate and 27% severe periodontitis. Questionnaire data revealed that 62.3% of the study subjects with severe periodontitis were not aware of the presence of the disease, 44.4% denied having received any systematic periodontal therapy so far, although 50% of them indicated to visit their dentist regularly for professional tooth cleanings. Conclusion: While the clinical study data confirm an increased prevalence of periodontitis in CKD patients, their self‐reported awareness of periodontitis was low. [ABSTRACT FROM AUTHOR]

Background Patients with chronic kidney disease (CKD) bear a substantial burden of comorbidities leading to the prescription of multiple drugs and a risk of polypharmacy. However, data on medication use in this population are scarce. Methods A total of 5217 adults with an estimated glomerular filtration rate (eGFR) between 30 and 60 mL/min/1.73 m2 or an eGFR ≥60 mL/min/1.73m2 and overt proteinuria (>500 mg/day) were studied. Self-reported data on current medication use were assessed at baseline (2010–12) and after 4 years of follow-up (FU). Prevalence and risk factors associated with polypharmacy (defined as the regular use of five or more drugs per day) as well as initiation or termination of polypharmacy were evaluated using multivariable logistic regression. Results The prevalence of polypharmacy at baseline and FU was almost 80%, ranging from 62% in patients with CKD Stage G1 to 86% in those with CKD Stage G3b. The median number of different medications taken per day was eight (range 0–27). β-blockers, angiotensin-converting enzyme inhibitors and statins were most frequently used. Increasing CKD G stage, age and body mass index, diabetes mellitus, cardiovascular disease and a history of smoking were significantly associated with both the prevalence of polypharmacy and its maintenance during FU. Diabetes mellitus was also significantly associated with the initiation of polypharmacy [odds ratio (OR) 2.46, (95% confidence interval 1.36–4.45); P = 0.003]. Conclusion Medication burden in CKD patients is high. Further research appears warranted to address the implications of polypharmacy, risks of drug interactions and strategies for risk reduction in this vulnerable patient population. [ABSTRACT FROM AUTHOR]

Purpose: To investigate stereoscopic vision in patients with macular telangiectasia (MacTel) type 2 and correlate paracentral sensitivity loss to reduced stereoscopic function. Methods: In a prospective single-center study, 50 patients with MacTel type 2 and 25 age-matched controls were investigated. Stereoscopic function was evaluated with Lang I, Titmus, and TNO tests. Sensitivity of the central 16° was tested using fundus-controlled perimetry (microperimetry). Functional loss was quantified as depth, size, and localization of scotomata. Results: Both the Titmus and the TNO test revealed significantly reduced stereoscopic vision in patients compared to controls (p < 0.0001 for both). This applied even to patients with only relative or monocular paracentral scotoma. A strong correlation was observed for reduced stereoscopic vision with horizontal scotoma size and with the distance of scotomata from the foveal center. Conclusions: The results indicate that stereoscopic vision is impaired early in patients with MacTel type 2. A paracentral sensitivity loss, even if mild and limited to one eye, may considerably interfere with stereoscopic function despite normal visual acuity. Projection of paracentral scotomata within the patient's central visual field plays an important role in stereoscopic vision and should be considered when interpreting stereoscopic test results. [ABSTRACT FROM AUTHOR]

Purpose: Basal cell carcinoma (BCC) is a locally invasive skin tumor which can be subdivided into a circumscribed nodular and an invasive fibrosing subtype. There is increasing evidence that macrophages play an important role in interacting between tumor cells and their microenvironment, thereby affecting not only the invasive potential but also the patients’ prognosis. Thus, we wanted to compare these two BCC variants with regard to tumor-related inflammation, COX-2 expression, distribution, and polarization of tumor-associated macrophages. Material and Methods: 30 BCCs (nodular: n = 15; fibrosing: n = 15) of the ocular adnexae were investigated by histopathology and immunohistochemistry. The grade of inflammation was evaluated on hematoxylin and eosin stains (score: 0-3). Immunohistochemical stains for CD68 (macrophages), Ki67 (proliferative activity), and COX-2 as well as immunofluorescence stains for CD68 and CD163 (to distinguish M1 and M2 macrophage subtypes) were performed. SPSS was used for statistical analysis. Results: Fibrosing BCCs were predominantly located on the lower lid, while nodular BCCs showed a broader distribution (p = 0.013). The fibrosing BCC subtype was associated with a higher degree of inflammation (p < 0.001) and revealed a higher COX-2 immunoreactivity than nodular BCC (p = 0.012). COX-2-positive cells were predominantly located on the infiltrating edge of the tumor. Macrophage polarization was balanced regarding M1 and M2 macrophage subtypes. There was no difference in macrophage number (p = 0.389) or polarization (p = 0.161) between nodular and fibrosing BCC. Conclusions: The findings indicate that COX-2 represents a factor for invasion of BCC. Macrophage polarization did not play a major role for aggressive behavior. However, other inflammatory components than tumor-associated macrophages seem to be involved in tissue destruction and thereby an invading growth pattern since fibrosing BCC revealed a significantly more intense inflammatory reaction in the surrounding tissue. [ABSTRACT FROM AUTHOR]

We assessed the prevalence, awareness, treatment and control of hypertension in patients with moderate chronic kidney disease (CKD) under nephrological care in Germany. In the German Chronic Kidney Disease (GCKD) study, 5217 patients under nephrology specialist care were enrolled from 2010 to 2012 in a prospective observational cohort study. Inclusion criteria were an estimated glomerular filtration rate (eGFR) of 30–60 mL/min/1.73 m2 or overt proteinuria in the presence of an eGFR>60 mL/min/1.73 m2. Office blood pressure was measured by trained study personnel in a standardized way and hypertension awareness and medication were assessed during standardized interviews. Blood pressure was considered as controlled if systolic < 140 and diastolic < 90 mmHg. In 5183 patients in whom measurements were available, mean blood pressure was 139.5 ± 20.4 / 79.3 ± 11.8 mmHg; 4985 (96.2%) of the patients were hypertensive. Awareness and treatment rates were > 90%. However, only 2456 (49.3%) of the hypertensive patients had controlled blood pressure. About half (51.0%) of the patients with uncontrolled blood pressure met criteria for resistant hypertension. Factors associated with better odds for controlled blood pressure in multivariate analyses included younger age, female sex, higher income, low or absent proteinuria, and use of certain classes of antihypertensive medication. We conclude that blood pressure control of CKD patients remains challenging even in the setting of nephrology specialist care, despite high rates of awareness and medication use. [ABSTRACT FROM AUTHOR]

Objectives: Coagulation factor XIII (FXIII) plays a key role in fibrin clot stabilization—an essential process for wound healing following cardiothoracic surgery. However, FXIII deficiency as a risk for post-operative bleeding in pediatric cardiac surgery involving cardiopulmonary bypass (CPB) for congenital heart disease (CHD) is controversially discussed. Thus, as primary outcome measures, we analyzed the association of pre-operative FXIII activity and post-operative chest tube drainage (CTD) loss with transfusion requirements post-operatively. Secondary outcomes included the influence of cyanosis and sex on transfusion. Methods: Our retrospective analysis (2009–2010) encompassed a single center series of 76 cardio-surgical cases with CPB (0–17 years, mean age 5.61 years) that were post-operatively admitted to our pediatric intensive care unit (PICU). The observational period was 48 hours after cardiac surgery. Blood cell counts and coagulation status, including FXIII activity were routinely performed pre- and post-operatively. The administered amount of blood products and volume expanders was recorded electronically, along with the amount of CTD loss. Uni- and multivariate logistic regression analysis was performed to calculate the associations (odds ratios) of variables with post-operative transfusion needs. Results: FXIII activities remained stable following CPB surgery. There was no association of pre- and post-operative FXIII activities and transfusion of blood products or volume expanders in the first 48 hours after surgery. Similarly, FXIII showed no association with CTD loss. Cyanosis and female sex were associated with transfusion rates. Conclusions: Although essentially involved in wound healing and clotting after surgery, FXIII activity does not serve as a valid predictor of post-operative transfusion need. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate two different spectral-domain optical coherence tomography (SD-OCT) scan patterns in eyes with intermediate age-related macular degeneration (AMD) for the longitudinal assessment of drusen volume. Methods: The data of 38 eyes of 38 AMD patients (age 69.97 ± 6.08 years) were included. The longitudinal drusen volume over 4 years was analyzed by annual SD-OCT raster scanning (field size 20 × 15°). Two raster scan patterns (A/B) differed in the distance between neighboring B-scans (240 vs. 30 µm) and in the number of averaged frames (4 vs. 15). Results: The mean drusen volume at baseline was 0.213 ± 0.100 mm3 (pattern A) and 0.219 ± 0.103 mm3 (pattern B) (p = 0.937). Linear mixed-effect models showed no significant difference for the change within 4 years for both pattern A (p = 0.8) and pattern B (p = 0.8). Conclusions: The results indicate that the performance of interpolation algorithms may be sufficient to balance for less dense raster scanning with regard to quantification of longitudinal drusen volume, which can be used as a surrogate marker for AMD progression in future clinical trials. [ABSTRACT FROM AUTHOR]

Background Aortic stiffness and epicardial fat relate to cardiovascular risk. Their relationship with each other and their role with hypertension, diabetes mellitus (DM), and myocardial infarction (MI) can be evaluated by cardiac magnetic resonance (CMR). Purpose To explore an association between aortic stiffness and epicardial as well as paracardial fat volume (EFV and ParaFV, respectively) in hypertensive patients and to relate the results to the presence of DM and MI. Material and Methods A total of 156 hypertensive and 20 non-hypertensive participants were examined at 1.5 Tesla. A 2D-velocity-encoded sequence was acquired to assess aortic pulse wave velocity (PWV in m/s) as a measure of aortic stiffness. A 3D-Dixon sequence was used to determine EFV and ParaFV. Results PWV correlated with EFV (R = 0.474; P < 0.001), but not with ParaFV. Fat volumes (in mL/m2) and PWV were lower in non-hypertensive controls compared to hypertensive patients. EFV and PWV were significantly higher in diabetic hypertensive patients without MI (n = 19; PWV: 10.4 ± 2.9; EFV: 92.5 ± 19.3) compared to hypertension-only patients (n = 84 [no DM or MI]; EFV: 64.8 ± 25.1, PWV: 9.0 ± 2.6; P < 0.05). Logistic regression analysis showed a significant association between the presence of a MI and a higher EFV ( P < 0.05), but not with PWV ( P = 0.060) or ParaFV ( P = 0.375). Conclusion A relationship between aortic stiffness and EFV was found in hypertensive patients. Both were increased in the presence of DM; however, only EFV was increased in the presence of MI. This may relate to the PWV lowering effect of the antihypertensive medication used by hypertensive patients and underscores the benefit of EFV assessment in this regard. [ABSTRACT FROM AUTHOR]

Introduction: Whereas sleeve gastrectomy (SG) in its beginnings was mainly performed to treat super-obesity, it has become as popular as gastric bypass in the treatment of obesity of any class. In contrast to this, the persisting problems of early staple line leaks and poor long-term results of SG regarding weight loss and new onset of gastroesophageal reflux have become increasingly obvious. The mini-gastric bypass (MGB) with its low complication rates and possibly better long-term results may be a good alternative to SG, especially in super-obesity.Methods: In this context, two groups of mostly super-obese patients (SG and MGB) of a single bariatric center were retrospectively analyzed and compared for perioperative and early postoperative outcomes.Results: Between August 2007 and March 2015, 169 patients underwent MGB, while 118 patients were operated by SG. Both groups were comparable for BMI at baseline (MGB = 54.1 kg/m2 vs. SG = 54.6 kg/m2, p = 0.657). Mean operation time (81.7 vs. 112.1 min, p < 0.0001) as well as hospital stay was lower in the MGB-group (4.5 vs. 7.2 days, p < 0.0001). Perioperative (30 days) mortality was 0 % in MGB versus 0.8 % in SG (one patient). Perioperative complication rate was also lower in the MGB-group (3.0 vs. 9.3 %, p = 0.449). %EWL was significantly better after 1 year in MGB: 66.2 % (±13.9 %) versus 57.3 % (±19.0 %) in SG (p < 0.0001), as well as BMI which was 34.9 kg/m2 (±4.8 kg/m2) in MGB versus 38.5 kg/m2 (±8.6 kg/m2) in SG (p = 0.001).Conclusions: MGB achieved superior weight loss at 1 year and had a lower 30-day complication rate in comparison with SG for super-obese patients. Thus, MGB might be superior to SG regarding the treatment of super-obesity. [ABSTRACT FROM AUTHOR]

Objectives: To retrospectively determine incidence of early arterial blood flow stasis and its influencing factors during resin-based radioembolization (RE) of liver tumours.Methods: Data of patients undergoing resin-based RE from 06/2006-12/2013 were reviewed. Second RE procedures of the same liver lobe were excluded. 90-yttrium dose was calculated according to the body surface area method. Data were categorized according to RE without full dose application because of early stasis and with full dose application. Clinical/procedural characteristics were recorded. Logistic regression was performed to identify associations between clinical/procedural characteristics and early stasis.Results: 362 patients [220 male; mean age 62 years (range 26-90)] underwent 416 RE sessions with early stasis occurring in 103 REs (24.8 %). Highest incidence and degree of stasis were observed in breast cancer metastases [42.6 % (20/47); 55.8 % of mean intended dose administered]. Independent risk factors were: metastasized breast cancer (odds ratio [OR] 2.18, p = 0.02), liver tumour-burden <25 % and 25-50 % (ORs 5.33, 15.64; p < 0.0001), tumour hypovascularity (OR 2.70, p = 0.04), previous bevacizumab therapy (OR 2.79, p = 0.0009) and concurrent chemotherapy (OR 8.69, p < 0.0001).Conclusion: Early stasis was observed in 24.8 % of resin-based REs. In the presence of the identified risk factors, extra care should be taken during microsphere administration.Key Points: • Early arterial blood flow stasis is a known problem of resin-based RE. • The study showed that early stasis occurs in 25 % of REs. • Several clinical and procedural factors are associated with early stasis. • In patients at risk extra care should be taken during RE. [ABSTRACT FROM AUTHOR]

Background: Diabetes mellitus (DM) is the leading cause of end-stage renal disease. Little is known about practice patterns of anti-diabetic therapy in the presence of chronic kidney disease (CKD) and correlates with glycaemic control. We therefore aimed to analyze current antidiabetic treatment and correlates of metabolic control in a large contemporary prospective cohort of patients with diabetes and CKD.Methods: The German Chronic Kidney Disease (GCKD) study enrolled 5217 patients aged 18-74 years with an estimated glomerular filtration rate (eGFR) between 30-60 mL/min/1.73 m(2) or proteinuria >0.5 g/d. The use of diet prescription, oral anti-diabetic medication, and insulin was assessed at baseline. HbA1c, measured centrally, was the main outcome measure.Results: At baseline, DM was present in 1842 patients (35 %) and the median HbA1C was 7.0 % (25(th)-75(th) percentile: 6.8-7.9 %), equalling 53 mmol/mol (51, 63); 24.2 % of patients received dietary treatment only, 25.5 % oral antidiabetic drugs but not insulin, 8.4 % oral antidiabetic drugs with insulin, and 41.8 % insulin alone. Metformin was used by 18.8 %. Factors associated with an HbA1C level >7.0 % (53 mmol/mol) were higher BMI (OR = 1.04 per increase of 1 kg/m(2), 95 % CI 1.02-1.06), hemoglobin (OR = 1.11 per increase of 1 g/dL, 95 % CI 1.04-1.18), treatment with insulin alone (OR = 5.63, 95 % CI 4.26-7.45) or in combination with oral antidiabetic agents (OR = 4.23, 95 % CI 2.77-6.46) but not monotherapy with metformin, DPP-4 inhibitors, or glinides.Conclusions: Within the GCKD cohort of patients with CKD stage 3 or overt proteinuria, antidiabetic treatment patterns were highly variable with a remarkably high proportion of more than 50 % receiving insulin-based therapies. Metabolic control was overall satisfactory, but insulin use was associated with higher HbA1C levels. [ABSTRACT FROM AUTHOR]

Purpose: To analyze and model visual acuity (VA) in geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Methods: The course of VA was analyzed using Turnbull's estimator in 226 eyes with uni- or bilateral GA due to AMD (151 patients; mean age 74.0 ± 7.6 years; mean follow-up time 33.4 ± 23.4 months) from the natural history FAM (Fundus-Autofluorescence Imaging in AMD) study. The variables 'age at baseline', 'gender', 'lesion size', 'diagnosis of the fellow eye', 'status of the fovea', 'focality of the lesion' and 'pattern' were evaluated for effects on predicting VA using linear mixed-effects models. Results: Mean VA at baseline was 0.6 (Snellen 20/80) ± 0.4 logMAR [range -0.1 to 1.8 (20/17 to hand motions)], showing an estimated mean increase of 0.181 (95% CI 0.152-0.210) and 0.256 (0.214-0.300) after 2 and 4 years of follow-up, respectively. The percentage of eyes with a loss of ≥ 3 lines was 34% by 2 years and 47% by 4 years. Linear mixed model analysis suggested that 65% of VA variability could be explained by the assessed predictor variables. The strongest effect was found for the 'status of the fovea' (0.69 logMAR units between 'definitively spared fovea' and 'definitive foveal involvement', p < 0.001). The second strongest effect was identified for 'total lesion size' (effects between 0.02 and 0.09 logMAR units for each mm depending on foveal involvement, p < 0.001, square root transformed values). Conclusions: These findings underscore the importance of GA lesion characteristics as these have the strongest impact on VA. Natural history data and modeling VA to other variables will be helpful for refining outcome parameters and estimating possible benefits of therapeutic interventions. [ABSTRACT FROM AUTHOR]

Purpose: To intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal(®) vascular closure device (VCD) and manual compression (MC) in a prospective study design.Methods: Patients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal(®)-VCD in one and MC in the other intervention. Patients were clinically and sonographically examined and were given questionnaires 1 day after intervention [groin- and back-pain during bedrest (100-point visual analog scale; 0: no pain); comfortability of bedrest (10-point Likert scale, 1: comfortable), satisfaction with closure (10-point Likert scale, 1: very satisfied)]. Results were analyzed in a cross-over design.Results: 48 patients (29 male, median age 62.5 (32-88) years) were included. An ExoSeal(®)-VCD was used first in 25 cases. As four of these subsequently refused MC as second intervention, data from 44 patients could be analyzed. All closures were technically successful (successful device deployment) without major complications. Groin- and back-pain after VCD-use/MC was 0 (0-15) vs. 10 (0-80) and 0 (0-75) vs. 25 (0-90), respectively (p < 0.0001). Bedrest after VCD-use was more comfortable than after MC [1 (range 1-7) vs. 6 (2-10); p < 0.0001]. Satisfaction with the closure procedure and with the intervention in general was higher after VCD-use compared to MC [1 (1-3) vs. 5 (2-10) and 1 (1-2) vs. 2 (1-4), respectively; p < 0.0001].Conclusion: Intra-individual comparison showed pain levels and discomfort to be significantly lower after ExoSeal(®) use compared to MC. VCD closure was associated with higher satisfaction both with the closure itself and with the intervention in general. [ABSTRACT FROM AUTHOR]

To investigate the impact of a caffeine and taurine containing energy drink (ED) on myocardial contractility in healthy volunteers using cardiac MR and cardiac MR based strain analysis. 32 healthy volunteers (mean age 28 years) were investigated before and 1 h after consumption of a caffeine and taurine containing ED. For assessment of global cardiac functional parameters balanced SSFP-Cine imaging was performed, whereas CSPAMM tagging was used to evaluate global and regional myocardial strain. In addition, ten randomly chosen subjects were investigated once more using a caffeine only protocol to further evaluate the effect of caffeine solely. Heart rate and blood pressure were recorded throughout all studies. ED consumption led to a significant increase in peak systolic strain (PSS) and peak systolic strain rate (PSSR) 1 h after consumption (PSS: w/o ED −22.8 ± 2.1 %; w ED −24.3 ± 2.4 %, P = <0.0001 and PSSR: w/o ED −1.2 ± 0.1 1/s; w ED −1.3 ± 0.2 1/s, P = 0.0056), which was not observed in the caffeine only group. In contrast, global left ventricular function was unchanged ( P = 0.2076). No significant changes of vital parameters and diastolic filling pattern were detected 1 h after ED consumption. Consumption of a caffeine and taurine containing ED results in a subtle, but significant increase of myocardial contractility 1 h after consumption. [ABSTRACT FROM AUTHOR]

Purpose: Laparoscopic surgery (LS) is gaining popularity worldwide because of benefits like faster recovery, earlier hospital discharge, and better cosmetic results. In hemophiliacs, surgery in general harbors an increased risk for severe complications. Whether LS or conventional surgery (CS) should be recommended in these patients is controversial and therefore the issue of our present study. Methods: We performed a retrospective matched-pair analysis including laparoscopically operated non-hemophiliacs (LONH), laparoscopically operated hemophiliacs (LOH), and conventionally operated hemophiliacs (COH) concerning duration of surgery, drainages, hospital stay, complications, factor use (VIII, IX, and X), and blood values. Mann-Whitney U test was used (significance level P = 0.05). Results: No significant differences were found in duration of surgery and drains in laparoscopically or conventionally operated hemophiliacs versus matched pairs. Complication rate did not differ among the different groups. Concerning the total duration of hospital stay (t-DHOS) and the postoperative duration of hospital stay (p-DHOS), there was no statistical difference between LOH versus matched LONH. However, in COH versus matched LOH, a longer time was required for preparation and recovery (t-DHOS, P = 0.04; p-DHOS, P < 0.001). Also, the median factor supply perioperatively including the day of surgery did not differ between laparoscopically versus conventionally operated hemophiliacs. Conclusions: Our study underscores the safety and benefits of laparoscopic procedures in hemophiliacs by showing a significantly shorter hospital stay for these patients resulting in reduced therapeutic costs and a faster mobilization. Still, the surgical and perioperative management of hemophiliacs continues to be a challenge requiring an experienced interdisciplinary team. [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate the efficacy of the fixed-dose combination olmesartan/amlodipine 40/10 mg in patients with moderate essential hypertension not controlled on candesartan 32 mg. This was a prospective, single-arm, phase IV study. The primary endpoint was the change in mean daytime systolic blood pressure (BP). A total of 77 of 89 screened patients started candesartan 32 mg, 62 olmesartan 40 mg, and 57 olmesartan 40 mg/amlodipine 10 mg. Mean daytime systolic BP was reduced by 9.8±15.2 mm Hg (P<.001) vs candesartan monotherapy. Office BP reduction was 9.2±18.8/5.0±8.9 mm Hg (P<0.001). Treatment goals (<140/90 mm Hg for office and <135/85 mm Hg for ambulatory BP) were achieved in 58.2% and 78.4% of patients, respectively. There was one drug-related adverse event (edema) and no serious adverse events. Patients of Caucasian ethnicity with moderate essential hypertension uncontrolled on candesartan experienced a further drop in BP using olmesartan and amlodipine. [ABSTRACT FROM AUTHOR]

The objective of this study was to investigate the efficacy of the fixed-dose combination olmesartan/amlodipine 40/10 mg in patients with moderate essential hypertension not controlled on candesartan 32 mg. This was a prospective, single-arm, phase IV study. The primary endpoint was the change in mean daytime systolic blood pressure (BP). A total of 77 of 89 screened patients started candesartan 32 mg, 62 olmesartan 40 mg, and 57 olmesartan 40 mg/amlodipine 10 mg. Mean daytime systolic BP was reduced by 9.8±15.2 mm Hg ( P<.001) vs candesartan monotherapy. Office BP reduction was 9.2±18.8/5.0±8.9 mm Hg ( P<0.001). Treatment goals (<140/90 mm Hg for office and <135/85 mm Hg for ambulatory BP) were achieved in 58.2% and 78.4% of patients, respectively. There was one drug-related adverse event (edema) and no serious adverse events. Patients of Caucasian ethnicity with moderate essential hypertension uncontrolled on candesartan experienced a further drop in BP using olmesartan and amlodipine. [ABSTRACT FROM AUTHOR]

Purpose: To determine the usefulness of acquiring extension radiographs for the evaluation of the degree of spondylolisthesis. Methods: Routine radiographs of the lumbar spine were retrospectively evaluated in 87 patients (mean-age 63, range 32-86) by two independent radiologists. All patients received radiographs in standing neutral, flexion and extension position. Vertebral body depth, sagittal translational displacement and lordosis angle were measured and slip percentage (SP) was calculated on standing neutral, flexion and extension radiographs. Statistical analysis was performed with a two-sided t test. Inter- and intraobserver reliability was assessed using the kappa-coefficient. Results: There was no statistically significant SP-difference between neutral standing and extension images. Ventral instability was diagnosed in 25-34 % (cut-off >8 % SP-difference) for neutral versus flexion comparison. The detection rate of flexion-extension radiographs representing the extremes of motion was lower with 15-22 %. Inter- and intraobserver reliability was good to excellent. Conclusion: Slip percentage in routine standing extension radiography ultimately does not differ from that obtained in a static neutral standing view. Extension radiography may therefore be omitted in a routine work-up of ventral instability in lumbar spondylolisthesis. [ABSTRACT FROM AUTHOR]

A direct switch of candesartan to the fixed-dose combination olmesartan/amlodipine in uncontrolled hypertension is a frequent clinical requirement but is not covered by current labeling. An open-label, prospective, single-arm phase IIIb study was performed in patients with 32 mg candesartan followed by olmesartan/amlodipine 40/10 mg. The primary endpoint was change in mean daytime systolic blood pressure (BP). Mean daytime systolic BP was reduced by 9.2±12.6 mm Hg (P<.0001) after substituting candesartan for olmesartan/amlodipine (baseline BP 140.2±9.7 mm Hg). The reduction in office BP was 9.4±18.4/4.0±9.6 mm Hg; P<.002). Overall, 61.3% of patients achieved a target BP <140/90 mm Hg using office BP and <135/85 mm Hg using ambulatory BP measurement. There were 8 adverse events with a possible relation to study drug and 1 unrelated serious adverse events. In conclusion, patients with uncontrolled moderate arterial hypertension being treated using candesartan monotherapy achieve a further reduction of BP when switched directly to a fixed-dose combination of olmesartan 40 mg/amlodipine 10 mg. [ABSTRACT FROM AUTHOR]

A direct switch of candesartan to the fixed-dose combination olmesartan/amlodipine in uncontrolled hypertension is a frequent clinical requirement but is not covered by current labeling. An open-label, prospective, single-arm phase IIIb study was performed in patients with 32 mg candesartan followed by olmesartan/amlodipine 40/10 mg. The primary endpoint was change in mean daytime systolic blood pressure (BP). Mean daytime systolic BP was reduced by 9.2±12.6 mm Hg ( P<.0001) after substituting candesartan for olmesartan/amlodipine (baseline BP 140.2±9.7 mm Hg). The reduction in office BP was 9.4±18.4/4.0±9.6 mm Hg; P<.002). Overall, 61.3% of patients achieved a target BP <140/90 mm Hg using office BP and <135/85 mm Hg using ambulatory BP measurement. There were 8 adverse events with a possible relation to study drug and 1 unrelated serious adverse events. In conclusion, patients with uncontrolled moderate arterial hypertension being treated using candesartan monotherapy achieve a further reduction of BP when switched directly to a fixed-dose combination of olmesartan 40 mg/amlodipine 10 mg. [ABSTRACT FROM AUTHOR]